StrataGraft® skin tissue

The Company’s flagship product, StrataGraft® skin tissue, is a viable, full-thickness skin substitute being developed for severe burns and other complex skin defects. It was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers. Unlike first generation skin substitutes, this resorbable tissue is easily sutured and remains intact in the wound bed, providing critical barrier functionality during the wound healing process.

StrataGraft is produced using unmodified NIKS® cells grown under standard operating procedures (SOPs). Because the continuous NIKS skin cell line has been thoroughly characterized, StrataGraft products are virus-free, non-tumorigenic, and offer batch-to-batch genetic consistency.

Target Market

There is an urgent need for new treatment options for burns. Severe burns and other major traumas to the skin are life-threatening injuries that require immediate surgical intervention. Typically, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration, as there are no full-thickness skin substitutes commercially available. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed has healed to the point that it will accept autograft tissue. Although this regimen is the standard of care for severe 2^nd degree deep partial thickness and 3^rd degree full thickness burns, limited availability of cadaver skin, the potential for transmission of pathogens from donor tissue, and the ultimate rejection of the cadaver skin pose serious drawbacks to this approach. Safe and effective alternatives to the use of cadaver skin are needed to improve the care of patients with these life-threatening wounds.

According to the American Burn Association, an estimated 1.1 million people suffer burns annually in the USA. Of these, approximately 45,000 patients are hospitalized for treatment, and 25,000 are admitted to 125 specialized burn centers located throughout the country. The cost burden of severe burns on the health care system is significant – mean per-patient hospital charges alone range from $27,000 to $156,000 for burns affecting less than 30% Total Body Surface Area, and can exceed $500,000 for more significant burns.

StrataGraft® offers important prospective benefits to this target market, including:

  •  Reduced patient pain, discomfort and infection risk due to fast wound closure;

  •  Elimination of, or a reduction in the size of, painful skin transplant (autograft) donor sites;

  •  Increased patient safety due to the virtual elimination of infection risks associated with contaminated cadaver skin currently used for temporary wound coverage;

  •  Potentially faster overall healing timeframes

  •  Shorter hospital stays and fewer surgeries resulting in lower costs to healthcare providers and payers.

Clinical Evaluation

Stratatech has completed a Phase I/IIa trial of its StrataGraft skin substitute in patients with third degree, full-thickness burns. The goal of the multi-center, 15-patient trial was to evaluate the safety and short term effectiveness of the StrataGraft skin substitute, compared to cadaver skin, the current standard of care for patients with major skin traumas that require temporary skin replacement before autografting. The primary clinical endpoint, autograft engraftment or “take” comparable to the standard of care, was achieved. There were no adverse or serious adverse events reported. The execution of this first-time-in-human study provided important insights into the safety and immunological parameters of this novel product. Two papers have been published reporting the details of the study and the related immunological assessment, respectively.

A proof-of-concept study focused on wound healing endpoints in patients with second degree, deep, partial-thickness burns is ongoing.